AIM:To analyze the reasons for screening failure and explore the influencing fac-tors in clinical trial in healthy volunteers,guidance was provided to improve the success rate of screen-ing in the future.clarify the reasons for the failure in healthy subjects(HS)screening,and to provide guidance for screening in phase Ⅰ clinical trials.METHODS:We performed a retrospective study that described the process of HS screening in phase Ⅰ clinical trials carried out in department of clinical pharmacology lab,Nanjing First Hospital be-tween 2019 and 2022.We analyzed the reasons for screening failure and their impact on the failure rate.A retrospective analysis was conducted on the data of subjects who participated in drug clinical trial screening 2019 to 2022.The reasons for screening failure were analyzed,and statistical methods were used to explore the independent factors that led to screening failure.RESULTS:A to-tal of 11 clinical trials were included in this study,and 502 out of 1 582 participants(31.7％)passed the screening.The analysis of the remaining 1 080 subjects showed that the items that did not pass the screening were laboratory examinations(631 cases,58.4％),abnormal vital signs results(228 cas-es,21.1％),intolerance to blood drawn(86 cases,8.0％),sufficient subjects(62 cases,5.7％),with-drawal at the screening(54 cases,5.0％),demogra-phy(54 cases,5.0％),urinary cotinine examination(42 cases,3.9％),imaging examination(31 cases,2.9％),electrocardiogram(24 cases,2.2％),inquiry(medical inquiry 19 cases,1.8％,smoking inquiry 2 cases,0.2％,alcohol inquiry 2 cases,0.2％)and identity verification(17 cases,1.8％).In the popula-tion with a body mass index(BMI)of 19.0 to 26.0,an increase in BMI is an independent factor signifi-cantly associated with screening failure(P＜0.000 1,OR=0.890 4,95％CI 0.841 9-0.941 3).The impact of different examination items on the screening fail-ure rate varies.CONCLUSION:In clinical trials of healthy subjects,laboratory tests,vital signs and in-tolerance to blood drawn are the main reasons for screening failure.Lowering the upper limit of BMI when recruiting subjects may increase the success rate of screening.Laboratory examinations,vital signs,intolerance to blood drawn are the most im-portant three reasons for screening failure,and im-provements can be made to reduce the screening failure rate of phase Ⅰ clinical trials in response to the main screening failure reasons.

Objective To investigate the influencing factors of adverse pregnancy outcomes in patients with recurrent spontaneous a-bortion(RSA),construct and validate the Nomogram risk prediction model.Methods A total of 219 patients with RSA admitted to the Second Affiliated Hospital of Kunming Medical University from March 2021 to March 2024 were selected and divided into the poor preg-nancy outcome group(n=129)and the good pregnancy outcome group(n=90)according to the pregnancy outcome.The case data was collected.Results There were statistically significant differences in the leukocyte esterase(LE)positive/negative,hydrogen peroxide(H2O2)positive/negative,bacterial vaginosis(BV),and gestational week of delivery between two groups(P＜0.05).The results of multivariate Logistic regression analysis showed that LE positivity(OR=10.677),H2O2 negativity(OR=3.796),and BV infection(OR=4.827)were the risk factors for adverse pregnancy outcomes in RSA patients,whereas an increase in the gestational week of deliv-ery(OR=0.294)was a protective factor.The area under the curve(AUC)of the Nomogram prediction model constructed based on this was 0.913.The validation results showed that the model had high discrimination,goodness of fit,calibration and net benefit for clinical decision-making.Conclusion Vaginal microecological imbalance and vaginal enzymatic alterations are correlate with adverse pregnancy outcomes in patients with RSA.The Nomogram prediction model constructed on the basis of LE,H2O2,BV and gestational week of deliv-ery can conveniently and efficiently assess the probability of adverse pregnancy outcomes in patients with RSA,and provide a basis for the early identification of high-risk patients and the prevention of the occurrence and development of RSA.

Objective:To construct and evaluate the nomogram prediction model of spontaneous rupture of primary liver cancer (STRPLC), and make the web-based dynamic online nomogram.Methods:Clinical data of 346 patients with PLC treated in the Second Affiliated Hospital of Kunming Medical University were retrospectively analyzed, including 87 males and 15 females, aged 58.15±10.32 years. Single factor and multiple factor logistic regression analysis were used to screen the influencing factors of STRPLC, and the prediction model was constructed based on the nomogram. Receiver operating characteristic (ROC) curve, calibration curve and clinical decision analysis were used to evaluate the model. The web-based dynamic online nomogram was developed using the DynNom package in R4.3.1 software.Results:Multivariate logistic regression analysis showed that the independent risk factors for spontaneous rupture and hemorrhage of tumor were no history of systematic anti-tumor therapy, alpha-fetoprotein (AFP) level, tumor protrusion on liver surface, tumor length, invasion of major blood vessels, and moderate to large amount of ascites (all P<0.05). The area under the receiver operating characteristic curve (AUC) of the prediction model constructed by this nomogram is 0.913 (95% CI: 0.884-0.943), the best cutoff value is 0.254, with a sensitivity of 0.892, and a specificity of 0.803. The calibration curve shows a good agreement between the predicted probability and the actual probability. The decision curve of the model is above the two invalid lines of " none" and " all" in the horizontal range of 0.07-0.98, and the clinical net benefit of the model is >0. Then user-friendly web-based dynamic online nomogram is constructed. Conclusion:Large tumor size, superficial location, no history of systematic anti-tumor therapy, high AFP level, invasion of major blood vessels, and moderate to large amount of ascites are independent risk factors for STRPLC. The prediction model and dynamic online nanogram constructed by this method can effectively assess the risk of STRPLC.

OBJECTIVE:To systematically evaluate the correlation between phase angle and sarcopenia and its diagnostic indexes.METHODS:The PubMed,EMbase,Cochrane Library,Web of Science,CNKI,WanFang Data,VIP and SinoMed databases were electronically searched to collect studies on the correlation between phase angle and sarcopenia and its diagnostic indexes from database inception to May 8,2024. Two reviewers independently screened literature,extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 and Stata 14.0 software. RESULTS:A total of 50 eligible articles were included. Meta-analysis results showed that compared with the non-sarcopenic population,the phase angle was significantly reduced in sarcopenic patients[standardized mean difference (SMD)=-0.99,95％ confidence interval (CI) (-1.09,-0.90),P<0.00001]. The results of subgroup analysis indicated that the difference of phase angle was more significant in patients with severe sarcopenia and Asian sarcopenia. Moreover,reduction in the phase angle was more obvious in patients with malignant tumors and respiratory diseases with sarcopenia. And skeletal muscle mass index (Pearson's r=0.565,P<0.00001),grip strength (Pearson's r=0.446,P<0.00001),and gait speed (Pearson's r=0.405,P<0.00001) all showed a moderate positive correlation with phase angle. However,appendicular skeletal muscle mass index showed a very weak positive correlation with phase angle (Pearson's r=0.139,P=0.02). CONCLUSION:Phase angle has a significant difference between sarcopenia and non-sarcopenia population,and it is correlated with the diagnostic indexes of sarcopenia to different extents. It suggests that phase angle has some clinical values in the objective diagnosis of sarcopenia. However,the results may be influenced by some factors such as sarcopenia severity and detection instruments of phase angle. Due to the limited quality and quantity of the included studies,more high-quality studies are needed to verify the above conclusion.

Objective To investigate the influencing factors of adverse pregnancy outcomes in patients with recurrent spontaneous a-bortion(RSA),construct and validate the Nomogram risk prediction model.Methods A total of 219 patients with RSA admitted to the Second Affiliated Hospital of Kunming Medical University from March 2021 to March 2024 were selected and divided into the poor preg-nancy outcome group(n=129)and the good pregnancy outcome group(n=90)according to the pregnancy outcome.The case data was collected.Results There were statistically significant differences in the leukocyte esterase(LE)positive/negative,hydrogen peroxide(H2O2)positive/negative,bacterial vaginosis(BV),and gestational week of delivery between two groups(P＜0.05).The results of multivariate Logistic regression analysis showed that LE positivity(OR=10.677),H2O2 negativity(OR=3.796),and BV infection(OR=4.827)were the risk factors for adverse pregnancy outcomes in RSA patients,whereas an increase in the gestational week of deliv-ery(OR=0.294)was a protective factor.The area under the curve(AUC)of the Nomogram prediction model constructed based on this was 0.913.The validation results showed that the model had high discrimination,goodness of fit,calibration and net benefit for clinical decision-making.Conclusion Vaginal microecological imbalance and vaginal enzymatic alterations are correlate with adverse pregnancy outcomes in patients with RSA.The Nomogram prediction model constructed on the basis of LE,H2O2,BV and gestational week of deliv-ery can conveniently and efficiently assess the probability of adverse pregnancy outcomes in patients with RSA,and provide a basis for the early identification of high-risk patients and the prevention of the occurrence and development of RSA.

AIM:To analyze the reasons for screening failure and explore the influencing fac-tors in clinical trial in healthy volunteers,guidance was provided to improve the success rate of screen-ing in the future.clarify the reasons for the failure in healthy subjects(HS)screening,and to provide guidance for screening in phase Ⅰ clinical trials.METHODS:We performed a retrospective study that described the process of HS screening in phase Ⅰ clinical trials carried out in department of clinical pharmacology lab,Nanjing First Hospital be-tween 2019 and 2022.We analyzed the reasons for screening failure and their impact on the failure rate.A retrospective analysis was conducted on the data of subjects who participated in drug clinical trial screening 2019 to 2022.The reasons for screening failure were analyzed,and statistical methods were used to explore the independent factors that led to screening failure.RESULTS:A to-tal of 11 clinical trials were included in this study,and 502 out of 1 582 participants(31.7％)passed the screening.The analysis of the remaining 1 080 subjects showed that the items that did not pass the screening were laboratory examinations(631 cases,58.4％),abnormal vital signs results(228 cas-es,21.1％),intolerance to blood drawn(86 cases,8.0％),sufficient subjects(62 cases,5.7％),with-drawal at the screening(54 cases,5.0％),demogra-phy(54 cases,5.0％),urinary cotinine examination(42 cases,3.9％),imaging examination(31 cases,2.9％),electrocardiogram(24 cases,2.2％),inquiry(medical inquiry 19 cases,1.8％,smoking inquiry 2 cases,0.2％,alcohol inquiry 2 cases,0.2％)and identity verification(17 cases,1.8％).In the popula-tion with a body mass index(BMI)of 19.0 to 26.0,an increase in BMI is an independent factor signifi-cantly associated with screening failure(P＜0.000 1,OR=0.890 4,95％CI 0.841 9-0.941 3).The impact of different examination items on the screening fail-ure rate varies.CONCLUSION:In clinical trials of healthy subjects,laboratory tests,vital signs and in-tolerance to blood drawn are the main reasons for screening failure.Lowering the upper limit of BMI when recruiting subjects may increase the success rate of screening.Laboratory examinations,vital signs,intolerance to blood drawn are the most im-portant three reasons for screening failure,and im-provements can be made to reduce the screening failure rate of phase Ⅰ clinical trials in response to the main screening failure reasons.

Objective:To construct and evaluate the nomogram prediction model of spontaneous rupture of primary liver cancer (STRPLC), and make the web-based dynamic online nomogram.Methods:Clinical data of 346 patients with PLC treated in the Second Affiliated Hospital of Kunming Medical University were retrospectively analyzed, including 87 males and 15 females, aged 58.15±10.32 years. Single factor and multiple factor logistic regression analysis were used to screen the influencing factors of STRPLC, and the prediction model was constructed based on the nomogram. Receiver operating characteristic (ROC) curve, calibration curve and clinical decision analysis were used to evaluate the model. The web-based dynamic online nomogram was developed using the DynNom package in R4.3.1 software.Results:Multivariate logistic regression analysis showed that the independent risk factors for spontaneous rupture and hemorrhage of tumor were no history of systematic anti-tumor therapy, alpha-fetoprotein (AFP) level, tumor protrusion on liver surface, tumor length, invasion of major blood vessels, and moderate to large amount of ascites (all P<0.05). The area under the receiver operating characteristic curve (AUC) of the prediction model constructed by this nomogram is 0.913 (95% CI: 0.884-0.943), the best cutoff value is 0.254, with a sensitivity of 0.892, and a specificity of 0.803. The calibration curve shows a good agreement between the predicted probability and the actual probability. The decision curve of the model is above the two invalid lines of " none" and " all" in the horizontal range of 0.07-0.98, and the clinical net benefit of the model is >0. Then user-friendly web-based dynamic online nomogram is constructed. Conclusion:Large tumor size, superficial location, no history of systematic anti-tumor therapy, high AFP level, invasion of major blood vessels, and moderate to large amount of ascites are independent risk factors for STRPLC. The prediction model and dynamic online nanogram constructed by this method can effectively assess the risk of STRPLC.

OBJECTIVE:To systematically evaluate the correlation between phase angle and sarcopenia and its diagnostic indexes.METHODS:The PubMed,EMbase,Cochrane Library,Web of Science,CNKI,WanFang Data,VIP and SinoMed databases were electronically searched to collect studies on the correlation between phase angle and sarcopenia and its diagnostic indexes from database inception to May 8,2024. Two reviewers independently screened literature,extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 and Stata 14.0 software. RESULTS:A total of 50 eligible articles were included. Meta-analysis results showed that compared with the non-sarcopenic population,the phase angle was significantly reduced in sarcopenic patients[standardized mean difference (SMD)=-0.99,95％ confidence interval (CI) (-1.09,-0.90),P<0.00001]. The results of subgroup analysis indicated that the difference of phase angle was more significant in patients with severe sarcopenia and Asian sarcopenia. Moreover,reduction in the phase angle was more obvious in patients with malignant tumors and respiratory diseases with sarcopenia. And skeletal muscle mass index (Pearson's r=0.565,P<0.00001),grip strength (Pearson's r=0.446,P<0.00001),and gait speed (Pearson's r=0.405,P<0.00001) all showed a moderate positive correlation with phase angle. However,appendicular skeletal muscle mass index showed a very weak positive correlation with phase angle (Pearson's r=0.139,P=0.02). CONCLUSION:Phase angle has a significant difference between sarcopenia and non-sarcopenia population,and it is correlated with the diagnostic indexes of sarcopenia to different extents. It suggests that phase angle has some clinical values in the objective diagnosis of sarcopenia. However,the results may be influenced by some factors such as sarcopenia severity and detection instruments of phase angle. Due to the limited quality and quantity of the included studies,more high-quality studies are needed to verify the above conclusion.

Objective:To analyze the effects of basic treatment of periodontal diseases combined with orthodontic treatment on periodontal pocket depth and bleeding index (BI) in patients with anterior tooth displacement caused by periodontal diseases.Methods:A total of 136 patients with anterior tooth displacement due to periodontal disease treated in the Second People′s Hospital of Yueqing from October 2020 to October 2022 were enrolled and they were divided into two groups by random number table method, and each group with 68 cases. The control group was given basic treatment for periodontal disease, while the experimental group was combined with orthodontic treatment on the basis of the control group. The clinical efficacy, masticatory efficiency, periodontal pocket depth (PD), probing BI, gingival sulcus inflammatory factors and the total incidence of complications were compared between the two groups.Results:The total effective rate in the experimental group was higher than that in the control group: 95.59%(65/68) vs. 79.41%(54/68), there was statistical difference ( P<0.05). After treatment for 3 months, the masticatory efficiency in the experimental group was higher than that in the control group, and PD, BI in the experimental group were lower than that in the control group: (70.52 ± 6.88) % vs.(61.52 ± 4.04) %, (2.12 ± 0.62) mm vs. (3.18 ± 0.85) mm, (1.26 ± 0.26) scores vs. (2.42 ± 0.33) scores, there were statistical differences ( P<0.05). After treatment, the levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and IL-8 in the experimental group were lower than those in the control group: (11.16 ± 1.85) μg/L vs. (16.92 ± 2.84) μg/L, (8.16 ± 1.34) ng/L vs. (15.49 ± 2.74) ng/L, (6.18 ± 1.46) ng/L vs. (10.33 ± 1.75) ng/L, there were statistical differences ( P<0.05). The total complication rate in the experimental group was lower than that in the control group: 1.47%(1/68) vs. 11.76%(8/68), there was statistical difference ( P<0.05). Conclusions:Basic treatment of periodontal diseases combined with orthodontics can effectively improve the masticatory efficiency of patients with anterior tooth displacement caused by periodontal diseases, reduce PD,BI and alleviate gingival sulcus inflammation, and reduce the incidence complications.

Based on Yichang health big data platform, 850 608 patients from September 2018 to September 2019 were included in this study. According to the date of birth, the participants were divided into early childhood famine exposure group, fetal famine exposure group and non-famine exposure group. The incidence of adult herpes zoster (HZ) in Yichang city was analyzed, and the correlation between early life famine exposure and adult HZ was analyzed. In 2019, the crude incidence rate of adult HZ in Yichang was 6.83‰. The crude incidence rate of adult HZ in females (7.26‰) was higher than that in males (6.40‰). Compared with the non-famine exposure group, fetal famine exposure was associated with the incidence of adult HZ ( OR=1.21; 95% CI: 1.01-1.45, P=0.041). After stratification by sex, fetal famine exposure was only found to be associated with the onset of adult HZ in females ( OR=1.28, 95% CI:1.02-1.61, P=0.034).